Feasibility and Safety of Robotic Assisted Proximal Gastrectomy With Double-flap Technique for Proximal Early Gastric Cancer

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05892289

Collaborator

First Affiliated Hospital of Guangxi Medical University (Other), First Affiliated Hospital of Kunming Medical University (Other), First Hospital of China Medical University (Other), Gansu Provincial Hospital (Other), Qilu Hospital of Shandong University (Other), Shandong Provincial Hospital Affiliated to Shandong First Medical University (Other), Sichuan Cancer Hospital and Research Institute (Other), Sichuan Provincial People's Hospital (Other), The First Affiliated Hospital of Zhengzhou University (Other), LanZhou University (Other), Third Affiliated Hospital, Sun Yat-Sen University (Other), Tianjin Medical University Cancer Institute and Hospital (Other), Zunyi Medical College (Other), Liaoning Tumor Hospital & Institute (Other), Qinghai Province Cancer Hospital (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Proximal early gastric cancer can choose radical total gastrectomy or proximal gastrectomy. The patients have poor nutritional status and quality of life after total gastrectomy. Compare to total gastrectomy, the nutritional status can improve after proximal gastrectomy . But if use simple esophagogastric anastomosis for proximal gastrectomy, the incidence of postoperative reflux esophagitis is high, which seriously affects the quality of life, and the short-term outcome is poorer than the total gastrectomy. If the incidence of postoperative reflux esophagitis can be reduced, proximal gastrectomy would be the treatment choice for proximal early gastric cancer, which may more improve both quality of life and nutritional condition than total gastrectomy.

Double-flap technique is a new surgical reconstruction procedure between esophagus and remnant stomach. It can reduce the occurrence of reflux oesophagitis through reconstruction a simulative cardia. At present, the technique has been carried out in some hospitals in China but still lack large-scale prospective studies and evidence of evidence-based medicine. At present, some retrospective studies have shown that robotic assisted proximal gastrectomy with double-flap technique is safe and effective, and the learning curve is shorter than laparoscopic surgery. The applicant have finished two robotic assisted proximal gastrectomy with double-flap technique cases. Two patients recovered well after surgery, with no occurrence of anastomotic leakage or stenosis and the postoperative quality of life was good. Now we plan to conduct a multi-center, single arm study on proximal early gastric cancer patients(T1N0-1M0 and T2N0M0) to evaluate the feasibility of robotic assisted proximal gastrectomy with double-flap technique , and to evaluate the surgical and oncological safety of this surgical method. Aim to provide initial evidence of evidence-based medicine for its clinical application..

Condition or Disease	Intervention/Treatment	Phase
Stomach Neoplasms	Procedure: Robotic assisted proximal gastrectomy with double-flap technique	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

42 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Feasibility and Safety of Robotic Assisted Proximal Gastrectomy With Double-flap Technique for Proximal Early Gastric Cancer: a Phase II, Multi-center, Single-arm Clinical Study

Anticipated Study Start Date :

Jun 10, 2023

Anticipated Primary Completion Date :

Dec 10, 2026

Anticipated Study Completion Date :

Dec 10, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Robotic assisted proximal gastrectomy with double-flap technique	Procedure: Robotic assisted proximal gastrectomy with double-flap technique Patients in this group receive robotic assisted proximal gastrectomy with D1+/D2 lymph node dissection(D1+ for stage IA：Nos.1, 2, 3a, 4 sa, 4 sb, 7, 8a, 9，11p；D2 for stage IB: Nos.1, 2, 3a, 4 sa, 4 sb, 7, 8a, 9，11p and 11d).The double-flap technique is used for the digestive tract reconstruction.

Arm

Intervention/Treatment

Experimental: Robotic assisted proximal gastrectomy with double-flap technique

Procedure: Robotic assisted proximal gastrectomy with double-flap technique

Patients in this group receive robotic assisted proximal gastrectomy with D1+/D2 lymph node dissection(D1+ for stage IA：Nos.1, 2, 3a, 4 sa, 4 sb, 7, 8a, 9，11p；D2 for stage IB: Nos.1, 2, 3a, 4 sa, 4 sb, 7, 8a, 9，11p and 11d).The double-flap technique is used for the digestive tract reconstruction.

Outcome Measures

Primary Outcome Measures

The Proportion of Patients With Reflux Esophagitis Within 12 Months Postoperatively [12 months postoperatively]
During follow-up endoscopy 1 year after surgery, reflux esophagitis were graded according to the Los Angeles (LA) classification.

Secondary Outcome Measures

Quality of Life after Surgery [Follow-up evaluations are performed 3, 6 and 12 months postoperatively]
Quality of life(QoL) is evaluated using the European Organization for Research and Treatment of Cancer (EORTC) 30-item core QoL (QLQ-C30 ver.3.0). Higher scores mean a worse outcome.
Gastrointestinal Symptoms after Surgery [Follow-up evaluations are performed 3, 6 and 12 months postoperatively]
gastrointestinal symptoms are assessed by Gastrointestinal Quality of Life Index (GIQLI) questionnaires. Higher scores mean a better outcome.
Changes in total protein at Follow-up [Follow-up evaluations are performed 3, 6 and 12 months postoperatively.]
blood total protein(g/L) levels
Changes in serum albumin at Follow-up [Follow-up evaluations are performed 3, 6 and 12 months postoperatively.]
blood serum albumin(g/L) levels
Changes in prealbumin at Follow-up [Follow-up evaluations are performed 3, 6 and 12 months postoperatively.]
blood prealbumin(g/L) levels
Changes in hemoglobin at Follow-up [Follow-up evaluations are performed 3, 6 and 12 months postoperatively.]
blood hemoglobin(g/L) levels
Changes in Vitamin B12 at Follow-up [Follow-up evaluations are performed 3, 6 and 12 months postoperatively.]
blood Vitamin B12(μg/ml) levels
Late Postoperative Morbidity [Follow-up evaluations are performed 3, 6 and 12 months postoperatively.]
adhesive ileus, anastomosis stenosis, malnutrition, dumping syndrome. All postoperative complications are classified according to the Clavien-Dindo(CD) classification standard.
Early Postoperative Morbidity [From surgery to discharge, up to 30 days]
operation wound with seroma, hematoma, infection, dehiscence, or evisceration, anastomotic leakage, anastomotic bleeding, abdominal bleeding, abdominal abscess, intestinal obstruction morbidity, gastrointestinal bleeding, gastroparesis, postoperative pancreatitis, pancreatic fistula, chylous leakage, lung morbidity, cerebrovascular morbidity, cardiovascular morbidity, deep vein thrombosis, cholecystitis, liver dysfunction, kidney dysfunction. All postoperative complications are classified according to the Clavien-Dindo(CD) classification standard.
Short-term Clinical Outcome After Surgery [From surgery to discharge, up to 30 days]
time to pass gas(hours)
Short-term Clinical Outcome After Surgery [From surgery to discharge, up to 30 days]
time to oral intake(hours)
Short-term Clinical Outcome After Surgery [From surgery to discharge, up to 30 days]
time to indwell gastric tube(hours)
Short-term Clinical Outcome After Surgery [From surgery to discharge, up to 30 days]
length of postoperative hospitalisation(days)
Surgical Characteristics [24 hours postoperatively]
operative time(minutes)
Surgical Characteristics [24 hours postoperatively]
time for reconstruction the digestive tract(minutes) during surgery
Surgical Characteristics [24 hours postoperatively]
blood loss during surgery(ml)
Quality of Life postoperatively [Follow-up evaluations are performed 3, 6 and 12 months postoperatively]
Quality of life(QoL) is evaluated using the European Organization for Research and Treatment of Cancer (EORTC) gastric cancer module (QLQ-STO22) questionnaire. Higher scores mean a worse outcome.
Pathological Characteristics [1 week postoperatively]
R0 resection rate. R0 resection represents complete resection of the tumor, meaning there is no residual tumor.
Pathological Characteristics [1 week postoperatively]
lymph nodes dissection extent for each patient in the surgery
Pathological Characteristics [1 week postoperatively]
number of dissected lymph nodes for each patient in the surgery
body mass index postoperatively [Follow-up evaluations are performed 3, 6 and 12 months postoperatively.]
body mass index(kg/m^2)
pain assessment postoperatively [Day 1 postoperatively]
We measured the pain score using visual analog scale(VAS) at 24 h after the surgery is completed. Higher scores mean a worse outcome.
Proportion of participants die after surgery [From surgery to discharge, up to 30 days]
mortality rate
Proportion of participants need to rehospitalized after surgery [From surgery to discharge, up to 30 days]
rehospitalization rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

20 years ≤ age ≤ 80 years
The primary gastric lesions were located in the proximal third of the stomach
histologically proven gastric adenocarcinoma (by preoperative gastrofiberscopy)
clinical stage IA (T1N0M0) or IB (T1N1M0 / T2N0M0) according to the 8th edition of the American Joint Committee on Cancer System(Clinical stage was determined based on the finding of endoscopic ultrasonography and/or thoraco-abdominal contrast-enhanced computed tomography)
scheduled for robotic assisted proximal gastrectomy with D1+/D2 lymphadenectomy, and possible for R0 surgery by this procedures (Lymphadenectomy is performed on the basis of the criteria of the Japanese Gastric Cancer Treatment Guidelines 2021 (6th edition).).
The preoperative American Society of Anesthesiologists (ASA) physical status was I-III;
The patient's cardiopulmonary function can tolerate robotic assisted surgery;
The subjects have signed the informed consent form.

Exclusion Criteria:

history of upper abdominal surgery and not suitable for robotic assisted surgery
the tumor invades the esophagus 3cm above gastro-esophageal junction (Z-line)
with other malignant diseases or have suffered from other malignant diseases within 5 years
Excessive tension for esophagogastric anastomosis and require changing the reconstruction procedure
women are pregnant or in lactation period
Suffering from serious mental illness
history of continuous systemic corticosteroid or immunosuppressive drug treatment within 1 month